Investigating Superion™ In Spinal Stenosis

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00692276
• Collaborator: VertiFlex, Incorporated (Industry)
• Enrollment: 391
• Locations: 32
• Arms: 2
• Duration (Months): 104
• Patients Per Site: 12.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Spinal Stenosis; Intermittent Claudication	Device: Superion™ Interspinous Spacer; Device: X-STOP® IPD® Device	N/A

Detailed Description

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care. The study endpoint is the rate of overall subject success at 24 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 391 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex® Superion™ Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®) System in Patients With Moderate Lumbar Spinal Stenosis
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Interspinous Process Spacer Device	Device: Superion™ Interspinous Spacer; Implantation of interspinous process spacer to treat lumbar spinal stenosis
Active Comparator: 2 Interspinous Process Spacer Device	Device: X-STOP® IPD® Device; Implantation of interspinous process spacer to treat lumbar spinal stenosis

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With Clinically Significant Improvement in Outcomes [Baseline and 24 months]

   Where clinically significant improvement in outcomes compared to baseline, as determined by meeting the following: At least two of three domains of the Zurich Claudication Questionnaire (ZCQ) [validated, condition-specific patient-reported questionnaire that captures data in three distinct domains] Improvement in physical function by ≥0.5 points Improvement in symptom severity by ≥0.5 points "Satisfied" or "somewhat satisfied" as defined by a score of ≤ 2.5 points on the patient satisfaction domain No re-operations, revisions, removals or supplemental fixation at the index level(s) No major implant- or procedure-related complications: No dislodgement, migration, or deformation No new or persistent worsened neurological deficit at the index level No spinous process fractures No deep infection, death, or other permanent device attributed disability No clinically significant confounding treatments: No epidural injections or nerve block proc

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female subjects ≥ 45 years of age

• Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart)

• Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal)

• Must be able to sit for 50 minutes without pain and to walk 50 feet or more

Exclusion Criteria:

• Axial back pain only

• Fixed motor deficit

• Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or experimental device

• Unremitting pain in any spinal position

• Significant peripheral neuropathy or acute denervation secondary to radiculopathy

• Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention

• Significant instability of the lumbar spine as defined by 3mm translation or 5 degrees angulation

• Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips

• Spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4)

• Spondylolysis (pars fracture)

• Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2

• Insulin-dependent diabetes mellitus

• Prior surgery of the lumbar spine

• Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction)

• Infection in the disc or spine, past or present

• Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease

• Tumor in the spine or a malignant tumor except for basal cell carcinoma

• Involved in pending litigation of the spine or worker's compensation related to the back

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Center for Neurosurgery	Phoenix	Arizona	United States	85020
2	Tucson Orthopaedic Institute	Tucson	Arizona	United States	85712
3	D.I.S.C. Sports and Spine Center	Beverly Hills	California	United States	90211
4	Tower Orthopaedics and Sports Medicine/ Institute for Advanced Spinal Research	Beverly Hills	California	United States	90211
5	Orange County Neurosurgical Associates	Laguna Hills	California	United States	92653-3665
6	Brain and Spine Research Institute	Los Angeles	California	United States	90027
7	Pacific Pain Medicine Consultants/Pacific Surgery Center	Oceanside	California	United States	92056
8	University of Colorado Hospital- The Spine Center- Anshutz Outpatient Pavilion	Aurora	Colorado	United States	80045
9	Durango Orthopedic Associates, P.C./Spine Colorado	Durango	Colorado	United States	81301
10	Colorado Spine And Scoliosis Institute	Littleton	Colorado	United States	80122
11	Yale University	New Haven	Connecticut	United States	06520
12	The George Washington Universtiy Medical Facility	Washington	District of Columbia	United States	20037
13	Florida Research Associates, LLC	DeLand	Florida	United States	32720
14	Shrock Orthopedic Research	Fort Lauderdale	Florida	United States	33316
15	Rush University Medical Center	Chicago	Illinois	United States	60612
16	Spine Institute of Louisiana	Shreveport	Louisiana	United States	71101
17	Greater Baltimore Neurosurgical Associates at GBMA	Baltimore	Maryland	United States	21204
18	Sports Medicine North	Peabody	Massachusetts	United States	01960
19	Institute for Low Back and Neck Care	Minneapolis	Minnesota	United States	55425
20	Orthopedics Associates of the Greater Lehigh Valley	Phillipsburg	New Jersey	United States	08865
21	Spine Care and Rehabilitation, Inc.	Roseland	New Jersey	United States	07068
22	Stony Brook University Medical Center, Dept. of Neurological Surgery	Stony Brook	New York	United States	11794
23	Upstate Medical Universtiy-Department of Orthopedics- Institute for Spine Care	Syracuse	New York	United States	13202
24	Triangle Orthopaedic Associates	Durham	North Carolina	United States	27704
25	NeuroSpine Institute, LLC	Eugene	Oregon	United States	97401
26	Performance Spine and Sports Physicians	Pottstown	Pennsylvania	United States	19464
27	OrthopaediCare (Abington Orthopaedic Specialists)	Willow Grove	Pennsylvania	United States	19090
28	New England Center for Clinical Research	Cranston	Rhode Island	United States	02920
29	East Tennessee Brain & Spine Center	Johnson City	Tennessee	United States	37604
30	Texas Back Institute	Plano	Texas	United States	75093
31	Orthopedics International Spine	Seattle	Washington	United States	98104
32	The Center for Pain Relief, Inc	Charleston	West Virginia	United States	25301

Sponsors and Collaborators

• Boston Scientific Corporation
• VertiFlex, Incorporated

Investigators

• Study Director: Roshini Jain, Boston Scientific Corporation

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 19, 2015

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT00692276
• Other Study ID Numbers: 08-VISS-01
• First Posted: Jun 6, 2008
• Last Update Posted: Nov 16, 2020
• Last Verified: Nov 1, 2020

• Additional relevant MeSH terms: Spinal Stenosis; Intermittent Claudication; Constriction, Pathologic

Study Results

Participant Flow

Arm/Group Title	1 - Study Treatment	2 - Active Control Treatment
Arm/Group Description	Interspinous Process Spacer Device Superion™ Interspinous Spacer: Implantation of interspinous process spacer to treat lumbar spinal stenosis	Interspinous Process Spacer Device X-STOP® IPD® Device: Implantation of interspinous process spacer to treat lumbar spinal stenosis
Period Title: Randomized Population
STARTED	190	201
COMPLETED	190	201
NOT COMPLETED	0	0
Period Title: Randomized Population
STARTED	190	201
COMPLETED	183	187
NOT COMPLETED	7	14

Baseline Characteristics

Arm/Group Title	1 - Study Treatment	2 - Active Control Treatment	Total
Arm/Group Description	Superion™ Interspinous Spacer	X-STOP® IPD® Device	Total of all reporting groups
Overall Participants	190	201	391
Age, Customized (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.9 (9.4)	66.2 (10.2)	66.5 (9.8)
Sex: Female, Male (Count of Participants)
Female	80 42.1%	72 35.8%	152 38.9%
Male	110 57.9%	129 64.2%	239 61.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 2.6%	11 5.5%	16 4.1%
Not Hispanic or Latino	185 97.4%	190 94.5%	375 95.9%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Clinically Significant Improvement in Outcomes
Description	Where clinically significant improvement in outcomes compared to baseline, as determined by meeting the following: At least two of three domains of the Zurich Claudication Questionnaire (ZCQ) [validated, condition-specific patient-reported questionnaire that captures data in three distinct domains] Improvement in physical function by ≥0.5 points Improvement in symptom severity by ≥0.5 points "Satisfied" or "somewhat satisfied" as defined by a score of ≤ 2.5 points on the patient satisfaction domain No re-operations, revisions, removals or supplemental fixation at the index level(s) No major implant- or procedure-related complications: No dislodgement, migration, or deformation No new or persistent worsened neurological deficit at the index level No spinous process fractures No deep infection, death, or other permanent device attributed disability No clinically significant confounding treatments: No epidural injections or nerve block proc
Time Frame	Baseline and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 - Study Treatment	2 - Active Control Treatment
Arm/Group Description	Interspinous Process Spacer Device Superion™ Interspinous Spacer: Implantation of interspinous process spacer to treat lumbar spinal stenosis	Interspinous Process Spacer Device X-STOP® IPD® Device: Implantation of interspinous process spacer to treat lumbar spinal stenosis
Measure Participants	183	187
Number [percentage of subjects]	52.7	50.2

Adverse Events

Time Frame	60 Months
Arm/Group Title	1 - Study Treatment		2 - Active Control Treatment
Arm/Group Description	Interspinous Process Spacer Device Superion™ Interspinous Spacer: Implantation of interspinous process spacer to treat lumbar spinal stenosis		Interspinous Process Spacer Device X-STOP® IPD® Device: Implantation of interspinous process spacer to treat lumbar spinal stenosis
All Cause Mortality
	1 - Study Treatment		2 - Active Control Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/190 (3.7%)		6/201 (3%)
Serious Adverse Events
	1 - Study Treatment		2 - Active Control Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	113/190 (59.5%)		117/201 (58.2%)
Blood and lymphatic system disorders
Anemia	2/190 (1.1%)	3	0/201 (0%)	0
Cardiac disorders
Angina	2/190 (1.1%)	2	0/201 (0%)	0
Coronary Episode, Ischemic	0/190 (0%)	0	2/201 (1%)	5
Dyspnea	0/190 (0%)	0	1/201 (0.5%)	1
Myocardial Infarction	5/190 (2.6%)	5	3/201 (1.5%)	3
Cardiovascular	7/190 (3.7%)	9	7/201 (3.5%)	9
Gastrointestinal disorders
Abdominal Pain	1/190 (0.5%)	1	0/201 (0%)	0
Gastrointestional Bleed	1/190 (0.5%)	1	1/201 (0.5%)	1
Nausea	0/190 (0%)	0	2/201 (1%)	2
Loss of bowel control	0/190 (0%)	0	1/201 (0.5%)	1
Gastrointestinal	4/190 (2.1%)	4	3/201 (1.5%)	3
General disorders
Edema	0/190 (0%)	0	1/201 (0.5%)	1
Fever	0/190 (0%)	0	2/201 (1%)	2
Other	37/190 (19.5%)	48	30/201 (14.9%)	38
Device dislodgement	0/190 (0%)	0	2/201 (1%)	2
Device migration	1/190 (0.5%)	1	3/201 (1.5%)	4
Device subsidence	1/190 (0.5%)	1	0/201 (0%)	0
Genitiurinary	8/190 (4.2%)	8	4/201 (2%)	4
Hepatobiliary disorders
Gallstones	0/190 (0%)	0	1/201 (0.5%)	1
Immune system disorders
Allergic Reaction	2/190 (1.1%)	2	1/201 (0.5%)	1
Infections and infestations
Deep Infection at the Operative Site	0/190 (0%)	0	2/201 (1%)	3
Infection	2/190 (1.1%)	2	1/201 (0.5%)	1
Pneumonia	6/190 (3.2%)	7	2/201 (1%)	2
Respiratory Infection	0/190 (0%)	0	1/201 (0.5%)	1
Urinary Tract Infection	0/190 (0%)	0	2/201 (1%)	2
Injury, poisoning and procedural complications
Soft Tissue Damage	0/190 (0%)	0	1/201 (0.5%)	1
Spinous Process Fracture	10/190 (5.3%)	11	5/201 (2.5%)	5
Vertebral Compression Fracture	0/190 (0%)	0	1/201 (0.5%)	1
Wound Dehiscence or Delayed Healing	0/190 (0%)	0	1/201 (0.5%)	1
Injury, accidental	4/190 (2.1%)	5	4/201 (2%)	4
Musculoskeletal and connective tissue disorders
Back pain	11/190 (5.8%)	11	14/201 (7%)	14
Pain - Buttock or Groin	3/190 (1.6%)	3	5/201 (2.5%)	6
Presence of Osteophyte Formation associated with Severe Disc or Facet Degeneration	0/190 (0%)	0	1/201 (0.5%)	1
Spinal Stenosis Symptoms at Index Level	22/190 (11.6%)	23	18/201 (9%)	19
Leg pain	11/190 (5.8%)	12	13/201 (6.5%)	14
Adjacent level degenerative disk disease	1/190 (0.5%)	1	0/201 (0%)	0
Adjacent level stenosis	0/190 (0%)	0	2/201 (1%)	3
Musculoskeletal	11/190 (5.8%)	12	19/201 (9.5%)	21
Pain - buttock	1/190 (0.5%)	1	0/201 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer/neoplasm	6/190 (3.2%)	7	6/201 (3%)	6
Nervous system disorders
Cerebrovascular Accident (CVA)	2/190 (1.1%)	2	1/201 (0.5%)	1
Dizziness	2/190 (1.1%)	2	0/201 (0%)	0
Dural Leak	6/190 (3.2%)	6	2/201 (1%)	2
Neurological Disorder	3/190 (1.6%)	3	3/201 (1.5%)	3
Stroke	4/190 (2.1%)	4	0/201 (0%)	0
Transient Ischemic Attack	0/190 (0%)	0	1/201 (0.5%)	1
Sensory loss	0/190 (0%)	0	1/201 (0.5%)	1
Renal and urinary disorders
Renal Failure	3/190 (1.6%)	3	1/201 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema	0/190 (0%)	0	1/201 (0.5%)	1
Pulmonary Embolism	1/190 (0.5%)	1	0/201 (0%)	0
Respiratory Disorder	2/190 (1.1%)	2	1/201 (0.5%)	1
Respiratory Distress	2/190 (1.1%)	2	0/201 (0%)	0
Chronic obstructive pulmonary disease (COPD)	1/190 (0.5%)	1	0/201 (0%)	0
Surgical and medical procedures
Wound Drainage	1/190 (0.5%)	1	0/201 (0%)	0
Vascular disorders
Deep Vein Thrombosis	1/190 (0.5%)	1	1/201 (0.5%)	1
Hematoma	0/190 (0%)	0	1/201 (0.5%)	2
Peripheral vascular disorder	0/190 (0%)	0	1/201 (0.5%)	1
Other (Not Including Serious) Adverse Events
	1 - Study Treatment		2 - Active Control Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	82/190 (43.2%)		100/201 (49.8%)
Cardiac disorders
Cardiovascular	20/190 (10.5%)	25	16/201 (8%)	20
Endocrine disorders
Endocrine/Metabolic	11/190 (5.8%)	11	11/201 (5.5%)	13
General disorders
Genitourinary	22/190 (11.6%)	25	17/201 (8.5%)	17
Other	14/190 (7.4%)	15	5/201 (2.5%)	10
Infections and infestations
Infection	14/190 (7.4%)	15	16/201 (8%)	17
Musculoskeletal and connective tissue disorders
Musculoskeletal	78/190 (41.1%)	108	70/201 (34.8%)	100
Pain - Back	50/190 (26.3%)	56	66/201 (32.8%)	71
Pain - Buttock and Groin	21/190 (11.1%)	23	13/201 (6.5%)	13
Pain - Leg	37/190 (19.5%)	41	47/201 (23.4%)	54
Spinal Stenosis at Index Level	35/190 (18.4%)	37	34/201 (16.9%)	38
Spinal Process Fracture	22/190 (11.6%)	24	13/201 (6.5%)	14
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer/Neoplasm	11/190 (5.8%)	13	13/201 (6.5%)	14
Nervous system disorders
Neurological Disorder	22/190 (11.6%)	27	13/201 (6.5%)	13

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.